Directors of EU medicines agencies met in Bratislava again to continue in discussion about the medicines regulatory issues.
The State Institute for Drug Control (ŠÚKL/SIDC) and the Institute for State Control of Veterinary Biologicals and Medicaments (ÚŠKVBL) hosted on 28 – 30 November 2016 the meeting of the Heads of Medicines Agencies (HMA II.). It was the last presidency meeting organized by the Slovak medicines agencies and also the only one which was hosted twice during the EU Slovak Presidency.
The HMA II. started by the meeting of HMA Management Group and continued with informal welcome buffet which took place in Austria Trend Hotel Bratislava.
The official part of the meeting was divided into several sessions. The NCAs directors met at breakfast meeting to discuss the sustainability of the regulatory network. After breakfast session, the meeting continued by veterinary and joint parts with focus on many important topics.
Big attention was paid to progress in Multi-Annual Work Plan (MAWP). The goals set out in MAWP led to necessity for establishing new working groups (Timely Access Working Group, Big data, Availability of Authorized Medicines for Human and Veterinary Use, Borderline products Working Group, Regulatory Optimisation Group). Adoption of mandates by HMA plenary has allowed the groups to work on achieving MAWP objectives instantaneously and continuously.
Information related to (un)availability of medicines were also mentioned, especially the results from EPSCO meeting and conference of shortage of medicines that was organized by Slovak Ministry of Health in Bratislava few weeks ago. As the issue of availability of appropriately authorised medicines has been chosen as a selected priority for 2016, the European Medicines Agency and HMA network have been working closely to join the forces, map the ongoing actions and discuss the future plans for moving this initiative forward.
Dr. Zuzana Batova, head of the SIDC, summarized the results from the scope of activities survey which was proceeded by the Slovak Medicines Agency. As dr. Batova informed „this initiative should have led to better knowledge of diverse competencies of NCAs, identification of shared interests and to possible new topics for further activities at the HMA level.”
Among others, operations of the EU Network Training Centre were presented with aim to continue in future to make available high quality training to the network, using the resources and expertise of the network and invest in e-learning modules.
As usually, information were given regarding the updates of European Communication, the European Medicines Agency and HMA Management Group.
The meeting continued by human session on 30 November 2016. The Heads were discussing the medical devices issues, big data initiative as well as successful results of the SCOPE project (Strengthening Collaboration for Operating Pharmacovigilance in Europe) which aim was to raise awareness of reporting adverse drug reactions in the EU member states.
The HMA is a network of heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulations of medicinal products for human and veterinary use in the European Economic Area. The HMA co-operates with the European Medicines Agency (EMA) and the European Commission in the operation of the European medicines regulatory network and it is a unique model for cooperation and work sharing on statutory as well as voluntary regulatory activities. The NCAs are responsible for the authorisation of many of the medicines available in Europe that are not authorised by the European Commission on the recommendation of the European Medicines Agency.